A study to ascertain gynaecological patients' perceived levels of embarrassment with physical and psychological care given by female and male nurses.

The Sex Discrimination Act lifted the barriers which prevented men from training and practising as midwives. However, cultural attitudes perceive nursing to be a female profession, and whilst care from a male doctor is considered to be acceptable, care from a male nurse is said to be embarrassing. The purpose of the study was to identify if there was any relationship between the intimacy of a nursing interaction and the patient's level of embarrassment. Data collection was by questionnaires with rating scales. Demographic data was obtained from nursing and medical notes. Statistical analysis was performed by non-parametric methods using Mini-tab. Ninety-one questionnaires were returned from a convenience sample of patients on a gynaecological oncology ward. Analysis of the data indicates that in a population of patients who have no prior experience of hospital admission, or of being cared for by a male nurse, there is a preference for care by a female nurse. However, this preference is not demonstrated in patients who have undergone previous hospital admission within the last five years or who have been cared for by a male nurse. These findings would indicate a cultural preference for care by a female nurse in patients with gynaecological cancer that is changed by experience during hospital admission.

Computerized axial tomographic scan measurements as prognostic indicators in patients with cervical carcinoma.

This retrospective study of 56 patients with carcinoma of the uterine cervix treated with radical radiotherapy at the Royal Marsden Hospital, London, examined whether simple measurements of maximum tumour dimension from computerized axial tomographic (CT) scans have any prognostic significance. Our results indicate that tumour depth (i.e. maximum antero-posterior dimension) of 4 cm or more is associated with a statistically significant increased relative risk of death of 2.4 (95% CI 1.1-5.5; p = 0.045), as compared with tumours with a depth of less than 4 cm. In addition, there was a clear correlation between tumour depth and lymph node involvement (r = 0.36; p < 0.01), and tumour depth and width (r = 0.70; p < 0.005). We suggest that a measurement of maximum tumour depth from the staging CT scan in these patients provides valuable additional information about likely occult lymph node metastases and prognosis, over and above that suggested by the FIGO staging system alone.

A randomized cross-over study of the efficacy of codeine phosphate versus Ispaghulahusk in patients with gynaecological cancer experiencing diarrhoea during pelvic radiotherapy.

Diarrhoea is the commonest acute complication during radiotherapy treatment to the pelvis. Codeine phosphate and a low residue diet is the standard therapy for radiation-induced diarrhoea at The Royal Marsden NHS Trust. The hypothesis put forward was that Ispaghulahusk and codeine phosphate were equally effective in the treatment of diarrhoea during radiotherapy. Participants in the study were female patients who had experienced change of bowel habit whilst receiving radiotherapy for their gynaecological cancer. Quantitative data was collected from patient diaries and treatment flow-sheets. Ten patients were randomized into the trial, five to codeine phosphate, and five to Ispaghulahusk. Continuing the trial was questioned after 10 patients had been treated. All five patients in the codeine phosphate arm received adequate control, while the five patients allocated to the Ispaghulahusk arm were all crossed-over to codeine phosphate with resolution of their diarrhoea. The results show that Ispaghulahusk, whilst not totally ineffective at controlling diarrhoea, was significantly less effective than codeine phosphate. Our conclusion is that there is insufficient reason to change to a less effective and less palatable preparation for the control of radiation-induced diarrhoea.

A matched control study of familial epithelial ovarian cancer: patient characteristics, response to chemotherapy and outcome.

BACKGROUND: Many of the characteristics of patients with familial epithelial ovarian cancer (EOC) are not yet well defined. This report describes some of the characteristics of patients with EOC in particular response rates to chemotherapy and 5-year survival, and compares them with matched controls with sporadic EOC. PATIENTS AND METHODS: There were 28 cases of familial epithelial ovarian cancer (EOC) presenting to the Royal Marsden Hospital from January 1983 to September 1993. The incidence of familial EOC over this time period was 2.2% (28/1268). For each case of familial EOC, 3 controls were selected and matched for age, FIGO stage, volume of residual disease after initial surgery and type of chemotherapy; the matched controls were compared to the familial EOC cases for differences in histological subtype, response to chemotherapy and 5-year survival. There was a statistically significant difference in histological subtype, 83% of patients with familial EOC had serous cystadenocarcinoma compared to 49% in the matched control group (p = 0.0025) providing evidence that familial EOC has a genetic basis. However there were no differences in median age or FIGO stage between patients with familial EOC and the sporadic cases and no difference in overall response to chemotherapy or 5-year survival. CONCLUSIONS: Our results imply that familial and sporadic EOC are biologically very similar and therefore molecular studies on the pathogenesis of and cellular mechanisms involved in EOC may have an important impact on therapeutic strategies for the much commoner sporadic form of the disease. In addition, our data suggest that all patients should be closely questioned with regard to family history not just those who present at a young age.

Is there still a role for lymphography in the management of early stage carcinoma of the cervix?

The value of lymphography in the management of carcinoma of the cervix is controversial and in many institutions has ceased to be used as part of routine staging. We present the results of 103 patients with carcinoma of the cervix treated by radical radiotherapy alone at the Royal Marsden Hospital between 1984 and 1990 all of whom had a staging lymphogram and computed tomography (CT) of the abdomen and pelvis as part of their routine staging prior to therapy. Our results show that 72 patients (70%) had no involved nodes detected on either CT or lymphography (LG--ve/CT--ve) while 16 patients (15.5%) were thought to have involved lymph nodes on lymphography alone but not on CT (LG+ve/CT-ve). The remaining 15 cases (14.5%) had involved lymph nodes on both CT and lymphography (LG+ve/CT+ve). There were no patients shown to have involved lymph nodes on CT with a negative lymphogram. Survival analysis on these three groups showed that patients in the LG+ve/CT+ve group did worse than the other two groups with only a 28% 5 year survival compared with 60% (LG-ve/CT-ve group) and 64% (LG+ve/CT-ve group) (p < 0.1). This effect of lymph node involvement disappeared in a multivariate analysis using Cox regression when stage came out as the strongest factor affecting survival. After controlling for stage, a further analysis of patients with only stage I and II disease has shown that patients who were LG+ve/CT+ve still did significantly (p < 0.05) worse (30% 5 year survival) than the other two groups: LG-ve/CT-ve group altered clinical management in 5/6 patients with stage I or IIA disease who avoided radical surgery and who were given a parametrial boost to the site of lymph node involvement. The possible benefit of this additional treatment to explain the higher survival rate of patients in the LG+ve/CT-ve group is discussed further. We conclude that lymphography still has a limited role to play in patients with early stage disease (I or IIA) who do not appear to have involved lymph nodes on CT scanning.

Multivariate analysis of factors affecting survival in pelvic exenteration.

Of 153 patients with primary or recurrent pelvic malignancy referred for consideration of exenteration, only 40.6% (62 patients) were found to be suitable for exenteration after full assessment. Thirty percent (46 patients) were found to be inoperable on examination under anesthesia. Of the remaining 107 patients, 33% (35 patients) were found to be inoperable at laparotomy, 9% (10 patients) underwent radical hysterectomy and 58% (62 patients) had an exenterative procedure. One patient had no active disease found on final histologic review of the exenteration surgical specimen and was excluded, as the aim of this study was to look at the prognostic factors affecting survival. There remained 61 patients in the exenteration group who were analyzed. The 2-year survival rate was less than 2% for patients with inoperable disease, 48% for patients who underwent radical hysterectomy and 54.1% for patients who underwent exenteration. The 5-year survival rate for all patients undergoing exenteration for pelvic malignancies was 44% and that for cervical cancer only was 52%. Multivariate analysis of patients who had undergone exenteration showed four significantly poor prognostic factors influencing survival. They were: (a) aged older than 69 years, (b) recurrence of the tumor within 3 years, (c) persistent recurrence, and (d) positive resection margins.

Long-term follow-up of the first randomized study of cisplatin versus carboplatin for advanced epithelial ovarian cancer.

PURPOSE: A phase III trial was performed between October 1981 and June 1984 to compare the efficacy of single-agent cisplatin and single-agent carboplatin in previously untreated patients with International Federation of Gynecology and Obstetrics stage III or IV carcinoma of the ovary following surgery. This report describes the survival rates of patients in this study after a minimum follow-up duration of 8 years. PATIENTS AND METHODS: Sixty-four patients were randomized to receive cisplatin and 67 patients to receive carboplatin. Cisplatin was administered every 4 weeks for a total of 10 courses, courses 1 to 5 at a dosage of 100 mg/m2 and courses 6 to 10 at 30 mg/m2. Carboplatin was administered at a dosage of 400 mg/m2 every 4 weeks for 10 courses. Patients who had clinical or radiologic evidence of response after five courses of chemotherapy underwent second-look surgery. The study was designed to allow crossover between the two arms. Thirteen patients were excluded from response analyses because they were incorrectly randomized. Patients were crossed over to the other arm of the study because of progressive disease (PD), nonresponse, or toxicity. RESULTS: The overall response rate for patients randomized to the cisplatin arm was 53.8% (28 of 52; 95% confidence interval [CI], 39% to 68%) and for those randomized to the carboplatin arm, 38.4% (20 of 52; 95% CI, 25% to 53%). There were 16 (30.8%) and 14 (26.9%) complete remissions (CRs) in the cisplatin and carboplatin arms, respectively. None of these differences were statistically significant. The median duration of response for the cisplatin and carboplatin arms was 21 months and 17 months, and the 5-year relapse-free survival rates were 22% and 25%, respectively. The median survival durations for the cisplatin and carboplatin arms were 19.5 and 13 months, and the 5-year survival rates were 15% (95% CI, 8% to 26%) and 19% (95% CI, 11% to 30%), respectively. None of these differences was statistically significant. The median follow-up duration of patients is 9 years. Crossover due to toxicity was more frequent in the cisplatin than the carboplatin arm, occurring in 50% and 3.3% of patients, respectively. CONCLUSION: The mature data from this study of patients with advanced ovarian cancer show that cisplatin and carboplatin have similar long-term survival results.

Relationship of computed tomography tumour volume to patient survival in carcinoma of the cervix treated by radical radiotherapy.

In this retrospective study tumour volume was calculated by two different methods from the staging computed tomographic scans obtained in 1987 of 20 patients with carcinoma of the cervix. All patients underwent treatment by radical radiotherapy and the survival figures at 5 years were analysed. The aim was to identify the nature of the relationship between the true tumour volume and tumour volume obtained by measuring the maximum dimensions in each plane ("cuboid" volume). Significant correlation between the product of height x width x depth and true tumour volume was demonstrated (r = 0.983). A multivariate analysis of survival demonstrated a significantly increased relative risk for positive nodes (p < 0.03) and tumour depth > 3.8 cm (p < 0.04) or tumour width > 5.0 cm (p < 0.03). A significant difference (p < 0.02) between the median tumour volumes for early and late stage disease was present irrespective of the method used to calculate tumour volume. This study demonstrates that cuboid tumour volume can be a good reflection of the true volume; in addition, positive nodes, tumour depth and tumour width are significant determinants of survival.

Steroid hormone profile in postmenopausal women with ovarian cancer.

Raised levels of steroid hormones are not expected in postmenopausal women. Therefore, if detected in postmenopausal women with ovarian cancer, they must be assumed to be related to the presence of the tumour and, therefore, may be of use as tumour markers. Serum levels of CA125, progesterone, 17-hydroxyprogesterone, sex hormone binding globulin and oestradiol were measured in 44 postmenopausal women with ovarian cancer, postsurgery and prior to chemotherapy. The relationship between the four hormone levels, CA125, patient age, stage, residual disease after surgery and differentiation were tested using the Spearman and Kendall rank coefficients. A significant inverse association was found between CA125 and progesterone levels, and CA125 and 17-hydroxyprogesterone. A positive association between 17-hydroxyprogesterone and progesterone was also found, and positive correlations between stage and CA125, and residual disease and CA125 were confirmed.

A randomised study of carboplatin vs sequential ifosfamide/carboplatin for patients with FIGO stage III epithelial ovarian carcinoma. The London Gynaecologic Oncology Group.

In a study designed to compare response rates of patients with stage III epithelial ovarian carcinoma to ifosfamide and carboplatin, 152 patients were randomised to receive either sequential therapy with three cycles of ifosfamide followed by three cycles of carboplatin, or to six cycles of single agent carboplatin. Ifosfamide was given every 3 weeks in a dose of 5 gm m-2 as a 24 h infusion with mesna, 1 gm m-2 by i.v. bolus prior to ifosfamide, 3 gm m-2 with ifosfamide, and 1 gm m-2 as an 8 h infusion after ifosfamide. Carboplatin was given in a dose of 400 mg m-2 by short i.v. infusion every 4 weeks. Sixty-eight evaluable patients were randomised to sequential ifosfamide/carboplatin, and 67 to single agent carboplatin. Median follow-up is 36 months (range 5.5-82.3). After three cycles of treatment two patients in the ifosfamide/carboplatin arm achieved complete remission (CR), and 12 partial remission (PR) for an overall response rate of 29%, whereas in the carboplatin arm ten patients achieved CR, and 23 PR, for an overall response rate of 63% (P = 0.0008). Seven of 15 patients with progressive disease, and nine of 20 patients with stable disease at the initial response evaluation, following three cycles of ifosfamide, subsequently responded to carboplatin therapy so that the final response rate to the complete regimen was 65% for the ifosfamide/carboplatin arm, compared to 71% for the carboplatin arm (NS). For the ifosfamide/carboplatin arm, median recurrence free survival and overall survival were 14.1 months and 18.7 months. Corresponding figures for the carboplatin arm were 14.5 months and 21.5 months (NS). Both treatments were generally well tolerated. However 47% of patients in the ifosfamide/carboplatin arm developed alopecia sufficient to require a wig, compared to only 2% in the carboplatin arm. Ifosfamide is clearly less effective, and more toxic than carboplatin. Ifosfamide failures can however be effectively salvaged by subsequent carboplatin treatment. Ifosfamide cannot be recommended for single agent therapy in ovarian carcinoma, however the combination of carboplatin plus ifosfamide might be a suitable treatment to be tested in a future randomised study against carboplatin alone.

Clear cell epithelial ovarian cancer (mesonephroid): bad prognosis only in early stages.

Clear cell ovarian carcinoma accounts for 4.5% of all cases of ovarian cancer at this center; 43% of patients presented with stage I disease. Stage for stage patients with advanced disease (II-IV) did no worse than other subtypes of epithelial tumors but patients with stage I disease did significantly worse at both 5 (P < 0.05) and 10 years (P < 0.02). Young age (< 60 years), advanced stage, and the presence of vascular invasion are independently poor prognostic factors, while the presence of a predominantly (> 75%) papillary or tubulocystic morphological pattern independently predicts a better prognosis.

Factors influencing local recurrence and survival in patients with soft tissue sarcoma of the upper limb.

Fifty-one patients with soft tissue sarcoma of the upper limb were studied to identify risk factors for local recurrence and survival. More than half (53 per cent) of the patients referred had locally recurrent disease. The flexor aspect of the forearm was the most common site of origin. The majority of patients were managed by a combination of conservative surgery and radical radiotherapy. Wide or radical excision was achieved in 49 per cent of cases. One-third of patients required partial resection of bone or neurovascular structures; 75 per cent of them had presented with local recurrence after treatment elsewhere. Skin grafts and flap repairs were used more often in patients with local recurrence (P = 0.013) and 20 (74 per cent) of those referred with locally recurrent disease have had no further local relapse. The overall 5-year survival rate of 80 per cent (95 per cent confidence interval 61-90 per cent) supports a policy of conservative surgery. Factors associated with a lower survival rate were deep fixation, origin in the flexor aspect of the forearm, and previous local recurrence. Deep fixation was also associated with an increased risk of local recurrence. Referral to a specialist unit at the time of initial presentation may result in lower rates of local recurrence and may improve the survival rate.

Limitations of surgery in the treatment of retroperitoneal sarcoma.

A retrospective analysis was undertaken of 120 patients with retroperitoneal sarcoma referred to the Royal Marsden Hospital over a period of 20 years. The actuarial 5-year survival rate of all cases following referral was 29 per cent. On univariate and multivariate analysis the principal factors associated with an unfavourable prognosis were the presence of metastases, poor performance status at presentation, high tumour grade and incomplete excision of the primary tumour. The single most important factor affecting the ability to remove the primary tumour completely was multiple organ involvement. After apparently complete excision, however, the probability of local recurrence by 5 years was 85 per cent (95 per cent confidence interval 56-99). The prognosis of patients with retroperitoneal sarcoma is poor.

Hormone replacement therapy and survival after surgery for ovarian cancer.

OBJECTIVE: To evaluate whether hormone replacement therapy affects survival in women who have undergone bilateral salphingo-oophorectomy because of epithelial ovarian cancer. DESIGN: Retrospective analysis by review of patients' notes and questionnaires completed by general practitioners to compare the overall survival and disease free survival in patients with ovarian cancer who did or did not receive hormone replacement therapy after diagnosis. Data were analysed by Cox regression, with hormone replacement therapy as a time dependent covariate because patients who received hormone replacement did so at different times after diagnosis. SETTING: Gynaecological oncology unit of Royal Marsden Hospital. PATIENTS: 373 patients aged 50 years or younger who attended the hospital from 1972 to 1988. All of the women had undergone bilateral salpingoophorectomy for epithelial ovarian cancer. In all, 78 had received hormone replacement therapy, starting at a median of four months after diagnosis. INTERVENTION: A questionnaire was sent to the general practitioners of all patients who were not recorded as having received hormone replacement therapy. MAIN OUTCOME MEASURES: Overall survival and disease free survival. RESULTS: There was no significant difference in survival between women receiving hormone replacement therapy and those not receiving it after accounting for the effects of other known prognostic factors (stage of cancer, differentiation of tumour, histological results, and time to relapse). The relative risk of dying in those who received hormone replacement therapy was 0.73 (95% confidence interval 0.44 to 1.20). In addition, there was no significant difference in disease free survival (relative risk in those receiving hormone replacement therapy was 0.90; 95% confidence interval 0.52 to 1.54). CONCLUSIONS: This study shows that hormone replacement therapy is unlikely to have a detrimental effect on the prognosis of patients with ovarian cancer, but this would be shown conclusively only by a randomised controlled trial.

Limb function following conservation treatment of adult soft tissue sarcoma.

Quality of life and limb function were studied in 54 patients who were disease-free 2 or more years after limb-conserving treatment for soft tissue sarcoma of the leg or pelvic girdle. Tumours of the thigh predominated (25 patients) and the mean tumour size was 9.9 cm. 41 patients had been treated with a combination of surgery and radiotherapy (29 with conventional and 12 with high dose), 12 with surgery alone and one with irradiation and intra-arterial doxorubicin. Only 15 patients had a normal range of movement in all lower limb joints and only 12 had normal power in all muscle groups; tumours of the lower leg were particularly unfavourable in this respect. Gait was normal in 42 patients but 8 required a walking aid and 4 a joint support. 16 had detectable lymphoedema but only 2 needed to wear compression hosiery. 35 patients still experienced pain at some time but only 6 required analgesia. However, when assessed by questionnaire for locomotion, grooming and home/leisure/vocational activities, 37 patients (68%) reported excellent function, and only 2 had moderate impairment. Function loss was most marked in leisure (25 patients) and vocational (8) activities, but was mild in 66% of cases. Multivariate analysis was carried out to determine the prognostic factors for poor limb function. The results suggested that overall functional score was predominantly determined by gait (P less than 0.001), muscle power or range of movement (P less than 0.001), with increasing age, female sex and the use of radiotherapy poor prognostic factors. Reduced muscle power or range of movement were the major factors determining gait (P less than 0.02) with the use of radiotherapy the significant prognostic factor for both in the conventionally treated group. Doses in excess of 60 Gy resulted in increased fibrosis and a worse functional outcome. Extent of surgery was not an independent prognostic factor for limb function, although univariate analysis suggested an association with range of movement in the conventionally treated group (P less than 0.025). Despite significant objective loss of range of movement and muscle power patients retain excellent limb function and quality of life following limb conserving treatment. For optimal function, radiotherapy should be given with small fractions to a dose not exceeding 60 Gy.

Treatment of extremity soft tissue sarcomas with surgery and radiotherapy.

The results of treatment with a combination of surgery and radiotherapy of 102 patients with nonmetastatic extremity soft tissue sarcoma are reported. Seventy-nine patients were previously untreated and 23 had locally recurrent disease. Sixty-six tumours were situated in the lower limb and 16 in the limb girdles. Fifty-nine were high grade lesions, and 64 were over 5 cm in length. Surgical clearance was "good" (wide or radical) in only 34 cases. Sixty-eight patients received post-operative irradiation, 23 pre-operative irradiation and 11 both pre- and post-operative radiotherapy. Seventeen patients subsequently developed local recurrence and 9 of these remain disease-free after further surgery. Actuarial 5 year local control and disease-free survival rates for new cases were 87 and 65.4%; and for previously recurrent cases these figures fell to 75 and 54.8%. Following a univariate analysis of patient, tumour, surgical and radiotherapeutic factors only previous local recurrence (p less than 0.1 greater than 0.05) was found to significantly increase the risk of further local relapse. Multivariate analysis found high tumour grade [relative risk (RR) 8.4], tumour size greater than 15 cm (RR 3.66), previous local recurrence (RR 6.47) and proximal site (RR 12.7) to be independent poor risk factors for survival.

Treatment of relapsed carcinoma of the ovary with cisplatin or carboplatin following initial treatment with these compounds.

Fifty-four patients with ovarian cancer who achieved a complete or partial remission with cisplatin or carboplatin were rechallenged with the same drug or crossed over to the other platinum compound at relapse. Fifteen of 43 (35%) crossover patients and 1/11 (9%) rechallenged patients responded; the difference was not significant and there was no difference in survival between the two groups. Responders survived significantly longer than nonresponders (P = 0.001) but there was no survival difference between those who responded to a rechallenge and those who responded to crossing over to the other platinum compound. The progression-free interval between the end of initial treatment and relapse was a significant prognostic factor for response to treatment and survival; 17% (6/35) of patients who relapsed before 18 months responded as compared to 53% (10/19) who relapsed after 18 months (P = 0.006) and median survival was 221 and 486 days, respectively, for these two groups (P = 0.026).

Carboplatin and ifosfamide in ovarian cancer phase II and III trials. London Gynaecological Oncology Group.

Over the past few years controversy has continued as to whether alkylating agents such as cyclophosphamide or chlorambucil are as effective as cisplatin in advanced ovarian cancer. Arguments have also been put forward against the use of combination chemotherapy, which is clearly more toxic than single-agent treatment and is probably no more effective than a single-agent platinum compound except in terms of producing a higher response rate. Certainly survival is not improved.

The prognostic significance of the half-life of serum CA 125 in patients responding to chemotherapy for epithelial ovarian carcinoma.

Various prognostic factors were studied in 29 patients with stage III or IV ovarian cancer who responded to initial chemotherapy after initial diagnostic surgery. The half-life of CA 125 in serum during initial chemotherapy was the most important prognostic indicator for survival (P less than 0.001) and the chance of achieving complete remission (P = 0.012). A CA 125 half-life of less than 20 days, 20-40 days and greater than 40 days appears to identify patients with a good, intermediate or poor prognosis, the two year actuarial survival being 76%, 48% and 0% respectively. The change of achieving a complete remission was 15% and 67% respectively for patients with a serum CA 125 half-life of greater than 20 or less than 20 days.